Lilly's Reyvow becomes first FDA-approved 5-HT1F receptor agonist for acute migraine

Eli Lilly has announced that the FDA has given the green light to Reyvow (lasmiditan) in the acute treatment of migraine, with or without aura, in adult patients. According to the regulator, this marks the first and only FDA approval of a serotonin (5-HT)1F receptor agonists in this treatment area.

Supporting the approval were data from two Phase 3 studies, both of which met their primary endpoints of pain freedom and freedom from most bothersome symptoms – including nausea, light sensitivity and sound sensitivity – two hours following administration, compared to placebo.

Reyvow will now be made available in retail pharmacies within 90 days of this approval as the FDA reviews additional human abuse potential assessment data supplied by Lilly for the drug, as is required for every therapy with CNS activity that the regulator evaluates.

"As a physician who specializes in the treatment of migraine and headache disorders, I commonly treat patients who are looking for acute treatment options that offer the chance for pain freedom during migraine attacks. This approval is especially significant because migraine pain is so often severe and incapacitating," explained Dr Jan Brandes, Assistant Clinical Professor, Department of Neurology at Vanderbilt University. "With new science comes new hope. Considering up to 40% of people with migraine do not get adequate responses from their initial acute treatment prescription, having a new and novel option like Reyvow is an important development for physicians and the patients we treat."

Dr Gudarz Davar, Vice President, Neurology Development at Lilly Bio-Medicines, added: "Millions of people with migraine face an ongoing battle with the unresolved pain and symptoms of a migraine attack. There is a substantial unmet need for new acute treatments for migraine, like Reyvow, which is why we are proud of today's approval and Lilly's continuing contribution to the migraine community. New expectations have been set in migraine care; pain freedom is now the treatment goal for people living with migraine and those who treat them. At Lilly, we are pioneering innovative medicines to provide new options for patients with migraine.”

Matt Fellows